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Clinical Trials/NCT01265277
NCT01265277
Completed
Not Applicable

Changes in Sleep Patterns and Stress in Infants Entering Child Care: Implications for SIDS Risk

Rachel Moon, MD1 site in 1 country20 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sudden Infant Death Syndrome
Sponsor
Rachel Moon, MD
Enrollment
20
Locations
1
Primary Endpoint
Sleep efficiency
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.

Detailed Description

The overall aim of this study is to describe sleep patterns in infants as they transition from home to child care, including 24-hour sleep duration, changes in the timing of daytime naps, and changes in nocturnal sleep periods; to describe potential sleep disrupters, such as temperature, light and noise, in home and child care settings that may impact sleep quality and sleep patterns; to describe markers of parent and infant stress levels during the transition to child care; to describe markers of infant circadian rhythm during the transition to child care.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
June 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rachel Moon, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Rachel Moon, MD

MD

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • Infants who are less than 3 months of age from English-speaking families where one or both parents live in the household will be eligible to participate. If the infant will be entering child care, the infant must be entering a licensed child care center, and child care entry must be between 60 and 120 days of age.

Exclusion Criteria

  • S/he was born prematurely, with a gestational age less than 37 weeks at birth, or had a birth weight \<2500 grams (5-1/2 lbs)
  • S/he has any medical problems that require ongoing care by a subspecialty physician

Outcomes

Primary Outcomes

Sleep efficiency

Time Frame: Days -14 through +14

sleep efficieny is defined as the ratio of time spent asleep (total sleep time) to the amount of time spent in bed.

Secondary Outcomes

  • Sleep duration(Days -14 to +14)

Study Sites (1)

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